Lomaira for Childhood Obesity

(PTOS Trial)

Recruiting at 1 trial location

Overseen By Warren Peters, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Loma Linda University

Must not be taking: Weight loss drugs, Obesogenic drugs

Disqualifiers: Cancer treatment, Drug abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 37 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to treat toddler obesity by improving the toddler nutritional environment. Parents will participate in a free internet nutrition program and may also take obesity medication. These measures may improve the parental nutritional environment and in turn, improve the toddler nutritional environment as well.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prescription or over-the-counter weight loss medications and any obesogenic medications (medications that can cause weight gain) that cannot be substituted or stopped.

Is Lomaira safe for use in children with obesity?

There is limited information on the safety of drugs like Lomaira for children with obesity, as many drug labels do not include specific dosing or safety guidance for this population. This lack of information can lead to concerns about potential adverse effects when these drugs are used in children with obesity. ^{1 2 3 4 5}

How does the drug Lomaira differ from other treatments for childhood obesity?

Lomaira is a low-dose formulation of phentermine, which is typically used for short-term weight loss in adults, making it unique as it is being studied for use in children with obesity. Unlike other treatments like metformin or orlistat, Lomaira works by suppressing appetite, which may offer a different approach to managing weight in children. ^{4 6 7 8 9}

Research Team

Warren C Peters, MD

Principal Investigator

Loma Linda University (School of Public Health)

Eligibility Criteria

This trial is for parents or caregivers of toddlers who are dealing with obesity. Participants should be interested in improving their own and their toddler's nutritional environment through an online nutrition program. Some will also take a weight loss medication called Lomaira.

Inclusion Criteria

Adults self-identifying as Hispanic/Latino or African American ethnicity

Toddlers self-identifying as Hispanic/Latino or African American ethnicity

My child is between 1 and 3 years old.

Exclusion Criteria

My toddler is on medication that may cause weight gain and cannot be stopped.

I am currently receiving treatment for cancer.

Adults with a history of drug or alcohol abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents or caregivers are randomized to receive either an obesity drug or a placebo, while participating in the Full Plate Living lifestyle program

37 weeks

Regular visits for lab results, biometric measurements, and nutrition questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lomaira

Trial Overview The study is testing whether parents taking the Lomaira 8Mg Tablet, along with participating in a free internet nutrition program, can positively influence their toddler's nutritional environment and potentially reduce toddler obesity.

Participant Groups

Group I: Active Lomaira Active Control 1 Intervention

Participants will receive Lomaira 8mg for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal.

Group II: Placebo Active Control 1 Intervention

Participants will receive Placebo for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Findings from Research

Children with obesity often do not have appropriate drug dosing guidelines, leading to increased risks of adverse events and challenges for healthcare providers in managing their care.

The study emphasizes the need for well-designed pharmacokinetic (PK) trials and collaboration with the FDA to improve drug labeling and dosing information for this vulnerable population, which could significantly enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. Zimmerman, KO., Benjamin, DK., Becker, ML., et al.[2023]

Recent advancements in anti-obesity medications (AOMs), particularly glucagon-like peptide 1 receptor agonists and phentermine-topiramate, have shown promising safety and efficacy in treating pediatric obesity, as highlighted by clinical trials since 2020.

A comprehensive treatment approach that combines lifestyle modifications with ongoing pharmacotherapy is essential for improving long-term health outcomes in children and adolescents with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future pharmacotherapies for obesity in children and adolescents. Kelly, AS.[2023]

In a study of 6454 children and adolescents with obesity, participation in pediatric weight management programs led to a modest median decrease in body mass index (BMI), with significant improvements observed over 12 months.

Factors such as older age (≥12 years), greater severity of obesity, and Hispanic ethnicity were linked to better outcomes in BMI reduction, which also correlated with improvements in cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. Kumar, S., King, EC., Christison, AL., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Obesity and Pediatric Drug Development. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Current and future pharmacotherapies for obesity in children and adolescents. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for childhood obesity: present and future prospects. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Pediatric obesity: Causes, symptoms, prevention and treatment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Childhood obesity. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Research progresses on interventions of obesity in children and adolescents]. [2023]